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Toward European roadmap for the evaluation of digital medical devices

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Publié le vendredi 28 octobre 2022

The World Health Organisation currently lists more than 2 million devices with a medical purpose. These innovative health technologies are transforming the medical landscape. They have the potential to improve healthcare for patients, providers and payers but are also disrupting the European regulatory landscape. Although the integration of these technologies is a strategic priority for Europe, there is currently no harmonised framework for their evaluation and use. There is now a clear need for a consistent quality labelling to help citizens identify digital medical devices fulfilling basic medical standards and privacy criteria. This is why a new European taskforce was recently launched to address the issue. 

The objective of this taskforce is to define a common nomenclature for the different types of digital medical devices and to work on a harmonised process for their clinical evaluation as well as a proper regulatory framework at the European level. “We want to reach a consensus between competent agencies in several countries as it will facilitate the accessibility of these health technologies across Europe and should reduce barriers to market entry and reimbursement in the EU member states,” details Prof. Jochen Klucken, head of the Digital Medicine group at the Luxembourg Centre for Systems Biomedicine (LCSB) of the University of Luxembourg and member of the taskforce.

Academics, national agencies and EU organisations working together

The taskforce is chaired by the Ministerial Delegation for Digital Health of the French Ministry of Health, co-chaired by the European Network for Health Technology Assessment and coordinated by EIT Health. It brings together pan-European organisations, academic experts in the field of digital medicine and representatives of health technology assessment agencies from several European countries, including Germany, France, Luxembourg, Belgium, Finland, Austria, Denmark and Spain.

The tasks are currently divided in three work packages focusing on:

  • Harmonising the taxonomy for the different types of devices according to their application
  • Identifying a common European method for assessing digital medical devices while respecting the mandates of national authorities
  • Developing an evaluation framework to include the socio-economic dimension when integrating these devices into health systems

Key expertise from Luxembourg and neighbouring countries

France and Germany have newly established or upcoming fast track mechanisms for digital health applications. Their national procedures provide access to these devices for 73 million insured citizens in Germany and to 60 million citizens as part of the National Health Insurance Fund in France. As key members of the taskforce, they will share their experience regarding the implementation of a regulatory Health Technology Assessment framework.

Luxembourg is bringing academic know-how to the table, with the participation of Prof. Klucken, FNR PEARL Chair for Digital Medicine and head of a research group on the topic at the LCSB. He has a longstanding expertise in the development of wearable sensors for Parkinson’s patients and is now leading an interdisciplinary team working on assessing medical benefit of digital healthcare services, as well as the structural and procedural changes needed and the degree of social acceptance. “We want to understand how patient-centred, personalised healthcare technologies can be tailored to patients needs and integrated into the existing healthcare procedures,” explains Prof. Kluchen. “These devices have an enormous potential to improve healthcare but enabling digital medicine requires the development of new evaluation methods and a regulatory structure.” Prof. Klucken represents the University of Luxembourg within the taskforce and acts as the rapporteur. He also recently organised the Digital Medicine Conference in Luxembourg during which the first results of the work packages were presented.



Read the full press release from the French Ministry of Health >>


Images: Olivimages